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Hydra Single-centre Experience - Copenhagen, Denmark

ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSahajanand Medical Technologies Limited

About this trial

The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation

Full understanding and willing to provide informed consent to study enrolment

Disqualifiers

Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)

Refusal to provide informed consent to study enrolment

Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI

Patients with calcification on the annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator

Trial population

Patient with severe aortic valve stenosis

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Hydra Transcatheter Aortic Valve (THV) Series

    Device

    The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Primary safety endpoint

Early safety as defined by VARC-3, as composite of: * Freedom from all-cause mortality; * Freedom from all stroke; * Freedom from VARC 3 type 3-4 bleeding; * Freedom from major vascular, access-related, or cardiac structural complication; * Freedom from acute kidney injury stage 3 or 4; * Freedom from moderate or severe aortic regurgitation; * Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; * Freedom from surgery or intervention related to the device.

Time frame
30 days
2

Primary performance endpoint

Device success as defined by VARC-3, as composite of: * Technical success; * Freedom from mortality; * Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication; * Intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).

Time frame
30 days

Secondary outcomes

1

Technical success

Time frame
Immediately after procedure
2

Cardiovascular mortality

Time frame
30 days, and 1-year
3

All-cause mortality

Time frame
30 days, and 1-year
4

All stroke

Time frame
30 days, and 1-year

Other outcomes

Sponsors and contacts

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Sahajanand Medical Technologies Limited

Lead sponsor

Qmed Consulting A/S

Collaborator

Source ClinicalTrials.gov
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